Recruiting
Phase 1

V350A & V350B

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06655324

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Accepted

Interventions

V350A

V350B

Placebo

Study Details

Brief summary:

Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.

Conditions

Healthy

Study ID

NCT06655324

Start date

Dec 5, 2024

Status verified date

Sep, 2026

Completion date

Jul 17, 2028

Anticipated

Primary completion date

Jul 17, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health before randomization.
  • Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment.
  • Has any immunosuppressive medical condition or receive any immunosuppressive therapy.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: V350A

Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.

experimental: V350B

Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.

placebo comparator: Placebo

Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.

Interventions

V350A

Vaccination administered via intramuscular injection

V350B

Vaccination administered via intramuscular injection

Placebo

Vaccination administered via intramuscular injection

Primary outcome measure

  • Number of Participants with Solicited Injection Site Adverse Events (AEs) [ Time Frame: Up to approximately 6 months ]
  • Number of Participants with Solicited Systemic AEs [ Time Frame: Up to approximately 6 months ]
  • Number of Participants with Immediate AEs Following Vaccinations [ Time Frame: Up to approximately 6 months ]
  • Number of Participants with Unsolicited AEs [ Time Frame: Up to approximately 7 months ]
  • Number of Participants with Serious AEs [ Time Frame: Up to approximately 18 months ]
  • Number of Participants with Medically Attended Adverse Events (MAAEs) [ Time Frame: Up to approximately 18 months ]
  • Number of Participants with Events of Clinical Interest (ECIs) [ Time Frame: Up to approximately 18 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Alliance for Multispecialty Research, LLC ( Site 0008)

Recruiting

Kansas City, Missouri, United States, 64114

Contacts

Study Coordinator

816-943-0770

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)

Recruiting

Springfield, Missouri, United States, 65802

Contacts

Study Coordinator

417-831-2048

Velocity Clinical Research Lincoln ( Site 0004)

Recruiting

Lincoln, Nebraska, United States, 68510

Contacts

Study Coordinator

308-365-8900

Velocity Clinical Research, Omaha ( Site 0005)

Recruiting

Omaha, Nebraska, United States, 68134

Contacts

Study Coordinator

402-933-6500

Remington-Davis, Inc. ( Site 0017)

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Study Coordinator

614-487-2560

Lynn Health Science Institute ( Site 0010)

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

Study Coordinator

405-602-3939

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.